Pharmacokinetics of oral levonorgestrel and ethinylestradiol in women after Roux-en-Y gastric bypass surgery

Brito, Claudia Moreira de; Melo, Maria Edna de; Mancini, Márcio C.; Santo, Marco Aurélio; Cercato, Cíntia

doi:10.1016/j.soard.2020.12.007

Cited by 11 publications

(9 citation statements)

References 46 publications

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“…Ciangura et al showed reduced norgestrel levels six months after RYGB, however, these values were considered sufficiently high for a contraceptive effect 107 . De Brito et al showed no significantly reduced levonorgestrel and ethinylestradiol levels at least twelve months after RYGB with a mean of 3.8 years, in twenty women compared to matched controlled non-bariatric women 108 . Besides evaluation of the pharmacokinetics, evaluation of clinical outcomes after a period of prolonged treatment with oral contraceptives is important.…”

Section: Oral Contraceptivesmentioning

confidence: 97%

“… 71 De Brito et al showed no significantly reduced levonorgestrel and ethinylestradiol levels at least 12 months after RYGB with a mean of 3.8 years, in 20 women compared to matched controlled non‐bariatric women. 123 Besides evaluation of the pharmacokinetics, evaluation of clinical outcomes after a period of prolonged treatment with oral contraceptives is important. Furthermore, a reduced effect of oral contraceptives after biliopancreatic bypass was described by Gerrits et al 124 Two of the nine patients who used oral contraceptives postoperatively were unexpectedly pregnant.…”

Section: Overview Of Dosing Information On Commonly Used Drugs After ...mentioning

confidence: 99%

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Oral drug dosing following bariatric surgery: General concepts and specific dosing advice

Kingma

Burgers

Monpellier

et al. 2021

Brit J Clinical Pharma

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Bariatric or weight-loss surgery is a popular option for weight reduction. Depending on the surgical procedure, gastric changes like decreased transit time and volume and increased pH, decreased absorption surface in the small intestine, decreased exposure to bile acids and enterohepatic circulation, and decreased gastrointestinal transit time may be expected. In the years after bariatric surgery, patients will also substantially lose weight. As a result of these changes, the absorption, distribution, metabolism, and/or elimination of drugs may be altered.The purpose of this article is to report the general influence of bariatric surgery on oral drug absorption, and to provide guidance for dosing of commonly used drugs in this special population. Upon oral drug administration, the time to maximum concentration is often earlier and this concentration may be higher with less consistent effects on trough concentrations and exposure. Additionally, prescription of liquid formulations to bariatric patients is supported by some reports, even though the high sugar load of these suspensions may be of concern. Studies on extended release medications result in an unaltered exposure for a substantial number of drugs. Also, studies evaluating the influence of timing after surgery show dynamic absorption profiles. Although for this group a specific advice can be proposed for many drugs, we conclude that there is insufficient evidence for general advices for oral drug therapy after bariatric surgery implying that a risk assessment on a case-by-case basis is required for each drug.

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Section: Oral Contraceptivesmentioning

confidence: 97%

Section: Overview Of Dosing Information On Commonly Used Drugs After ...mentioning

confidence: 99%

Oral drug dosing following bariatric surgery: General concepts and specific dosing advice

Kingma

Burgers

Monpellier

et al. 2021

Brit J Clinical Pharma

View full text Add to dashboard Cite

show abstract

“…To minimize the bias from the follow-up period and type of surgery, only data with a follow-up period equal to or greater than 6 months after RYGB were included. Six types of drugs from 12 studies were selected ( Table 3 ) [ 13 14 15 16 18 19 20 21 22 23 24 25 ]. As mentioned above, the AUC of acetaminophen in Chen et al was analyzed in the AUC inf instead of the AUC last .…”

Section: Resultsmentioning

confidence: 99%

Considerations for clinical evaluation of the effects of bariatric surgery on the pharmacokinetics of orally administered drugs

Bae

Song

et al. 2022

Transl Clin Pharmacol

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Obesity has been a growing worldwide concern, and surgical intervention including bariatric surgery is considered as one of the options for treatment. However, there still is controversy over the change in pharmacokinetics (PKs) of drugs after the surgery. To investigate the potential covariates that can influence the area under the curve (AUC) and maximum plasma concentration (C max ), the design of previous studies was reviewed based on pre-determined eligibility criteria. Each study calculated the ratios of the AUC and C max before and after bariatric surgery. These studies investigated whether the PK parameters were affected by the time after the surgery or by the type of control group. The ratio of the AUC calculated in the early and late follow-up period was similar across Roux-en Y gastric bypass patients. No significant difference in the PK parameters was found between the pre-surgical patients and matched healthy subjects. However, certain control groups could be preferable depending on the purpose of the clinical trial. Although C max was inconsistent compared to the AUC, insufficient sampling of the time points may have caused such an inconsistency. This is the first article exploring the appropriate methodology in designing clinical studies for changes in the PK characteristics of orally administered drugs in patients with bariatric surgery.

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“…There are theoretical concerns that both malabsorptive and restrictive bariatric procedures could decrease absorption of oral contraceptives 38,39. Evidence from two recent pharmacokinetic studies40,41 suggests that absorption of combined oral contraceptives (COCs) is not significantly affected by Roux-en-Y gastric bypass (RYGB). There is inadequate evidence to inform the effect of any type of bariatric surgery on contraceptive effectiveness of POPs 42–44…”

Section: What Can Affect Effectiveness Of the Pop?mentioning

confidence: 99%

“…Two recent studies compared pharmacokinetics of a combined ethinylestradiol (EE) 30 μg/LNG COC in individuals who had undergone RYGB and matched controls who had not had bariatric surgery. De Brito et al 40 measured maximum plasma concentration (C max ), time to peak plasma level (T max ) and area under the curve (AUC 0-8 and AUC 0-∞ ) in 20 RYGB cases and 20 unoperated controls for 8 hours after a single dose of COC. There was no significant difference in EE pharmacokinetics.…”

Section: What Can Affect Effectiveness Of the Pop?mentioning

confidence: 99%

FSRH Guideline (August 2022) Progestogen-only Pills

2022

BMJ Sex Reprod Health

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Pharmacokinetics of oral levonorgestrel and ethinylestradiol in women after Roux-en-Y gastric bypass surgery

Cited by 11 publications

References 46 publications

Oral drug dosing following bariatric surgery: General concepts and specific dosing advice

Oral drug dosing following bariatric surgery: General concepts and specific dosing advice

Considerations for clinical evaluation of the effects of bariatric surgery on the pharmacokinetics of orally administered drugs

FSRH Guideline (August 2022) Progestogen-only Pills

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